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Post by lakers on Oct 2, 2017 15:45:10 GMT -5
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Post by lakers on Oct 2, 2017 15:41:02 GMT -5
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Post by lakers on Oct 1, 2017 17:59:29 GMT -5
Tomorrow we will likely learn about items 2, 3, 4 from: Near Term Milestones and Key Events Growth Trajectory Continues for Afrezza FDA Label Change Recapitalization International Expansion Announcements Receptor Life Sciences One Drop Collaboration Expansion of Payor Coverage Completion of STAT Trial (Afrezza+Dexcom IND Filing for Treprostinil Mike mentioned RLS as second pipeline. RLS failed applying for the company name several times. RLS backers are deep pocket. They can pump more money into the combined co. RLS needs the Danbury plant, TS. RLS's backers would acquire the plant, TS if needed. They have vested interest to prop up Mnkd. I would not be surprised if recap includes RLS's backers. Read more: mnkd.proboards.com/user/1882/recent#ixzz4uIi2cqSZ
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Post by lakers on Oct 1, 2017 15:02:44 GMT -5
Joey said: "It could have a wide range of meaning/interpretation from a simple acknowledgement from the FDA based on their response to the label change to a series of domino's that have been put into place based on that result. I see that tweet as one huge exhale of relief and vindication but that's just my interpretation."
Amen
Seems Matt wanted to do deal in Q2. BoD and Mike wanted to wait till after Label change. Disagreement led to Matt's ouster, perhaps??
Matt turned financially conservative after being burnt so many times? Mike the new blood wanted to gamble for better deals and recap after Label change?
Read 1Q17 ER slide.
On file and expect near term approval in one ME country Late stage partnering discussions in other jurisdictions.
Certainly, Matt lost credibility for not fulfilling 1Q17 promise, which undermined his ability to govern. Make sense that he was out for not having BoD's support.
Think Mike is right this time...
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Post by lakers on Oct 1, 2017 11:53:23 GMT -5
Not after his biggest contribution was Tresprotinil pre-NDA, PDUFA. He extended his stay until the pivotal 9/29/17. Bravo Ray! Welcome back the old pro Andrea ??
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Post by lakers on Oct 1, 2017 11:32:49 GMT -5
www.baystreet.ca/viewarticle.aspx?id=476418Baystreet Staff - Wednesday, September 27, 2017 GT Biopharma, Inc. Announces Corporate Update Conference Call with CEO Dr. Kathleen Clarence-Smith, CMO Dr. Raymond Urbanski and Chairman Anthony Cataldo [ACCESSWIRE] WASHINGTON, DC / ACCESSWIRE / September 27, 2017 / GT Biopharma Inc. (OTCQB: GTBP), a targeted immunotherapies company with close to market treatments for Central Nervous System (CNS) diseases (neurology and pain), will hold a conference call, hosted by www.biotechstocks.com, to discuss advancements made with the targeted immunotherapies currently in FDA clinical trials and its newly acquired CNS drugs. The call will start promptly at 4:15 pm EST on Monday, October 2, 2017. About GT Biopharma, Inc.: GT Biopharma is a pharmaceutical company developing innovative drugs focused on the treatment of cancer and other unmet medical needs. Its lead drug candidate, OXS-1550 (DT2219ARL) is a novel bispecific scFv recombinant fusion protein-drug conjugate composed of the variable regions of the heavy and light chains of anti-CD19 and anti-CD22 antibodies and a diphtheria toxin as its cytotoxic drug payload. OXS-1550 targets and binds to cancer cells expressing the CD19 receptor or CD22 receptor or both receptors. When OXS-1550 binds to cancer cells, they internalize the drug and are killed due to the cytotoxic payload. OXS-1550 has demonstrated encouraging results in early human clinical trials in patients with relapsed/refractory B-cell lymphoma or leukemia. OXS-3550 TriKE technology was developed by researchers at the University of Minnesota Masonic Cancer Center. As demonstrated in non-clinical models, this targeted immunotherapy directs NK cells to kill cancer cells while diminishing the drug-related toxicity and is anticipated to be to NK cells what CAR-T is to T-cells. Additionally, GT Biopharma is focused on acquiring or discovering and patenting late-stage, de-risked, and close-to-market improved treatments for Central Nervous System disease and shepherding the products through the FDA approval process to the NDA. Its CNS products currently include treatment for neuropathic pain, refractory epilepsies, the symptoms of myasthenia gravis, and motion sickness. [CNS, pain, epilepsies are the same fields targeted by RLS by different method. Could RLS be merged with Mnkd? Could Andrea Leone-Bay come back to Mnkd as CMO? Mike mentioned RLS as second pipeline. RLS failed applying for the company name several times. RLS backers are deep pocket. They can pump more money into the combined co. RLS needs the Danbury plant, TS. RLS's backers would acquire the plant, TS if needed. They have vested interest to prop up Mnkd. I would not be surprised if recap includes RLS's backers.]
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Post by lakers on Sept 30, 2017 12:49:22 GMT -5
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Post by lakers on Sept 30, 2017 11:36:07 GMT -5
I agree it's been a great week for PWDs. FreeStyle Libre Flash Afrezza New Label. Good thing Ray's last day is 9/29 to help Mike craft the technical side of PDUFA press release, CMO+Pharmacist. 670G w/ Guardian Sensor 3 AP : It’s two generations from where we are now in the U.S., different chemistry, entirely different build, different assembly lines, and different substrates. So, we have spent a lot of time perfecting the sensor. There’s a new specialized chip in it that’s looking for sensors that are drifting and if it sees a drift or what would become an outlier, it asks for another calibration; we call it a Smart Cal. If it can be brought back, it will continue to run closed-loop. If it cannot, it will stop running closed loop, so there is that safety mechanism of his sensor self-diagnostics continuously looking for a sensor drift. Beyond that, we’ve done a pivotal trial. We’ve looked at the data from the use of 670 both in our pivotal, the pivotal sensor trial and now that use at home in the real world and the Mart is excellent with two to three calibrations a day. It’s exactly what we want to be, 10% or less. So, we feel very confident in the sensor. The people using it feel very confident as well and then we got that special chip. If it does start to not perform, it informs the individual and stops running closed-loop if it can’t fix itself. We’ve got the next generation already on the drawing board. They’re very excited to team with the DreaMed group, with their fuzzy logic. So, the next generation algorithm will be, if you’d like it to be, a little bit more aggressive. So, we are excited about that, more automatic bolusing so that the patient is going to be asked to do less and less, and the device will do more and more. We are looking at the use with ultra-rapid-acting insulin to see how far that gets us down the line of not having to inform about an upcoming meal. So very excited about that pathway. we just released in Europe, hopefully in the U.S. pretty soon – a stand-alone sensor and straight to the cell phone. Along with it you’ll be able to get an app that we’ve been collaborating with IBM to have advanced analytics, really big data learning, machine learning, so that patients can start to understand their patterns and trends; see where there might be a problem with their overall management, including a big nutritional component if that’s what they’d like. Read more: mnkd.proboards.com/thread/8688/kaufman-medtronic-ultra-rapid-insulin#ixzz4uBFJh36U
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Post by lakers on Sept 29, 2017 18:10:41 GMT -5
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Post by lakers on Sept 27, 2017 23:21:08 GMT -5
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Post by lakers on Sept 26, 2017 18:26:50 GMT -5
EU process takes too long, not as populous as BRIC w/o R. Canada, Mexico make sense due to NAFTA's no tariff (Sorry, Novo, Sanofi) and shorter approval process. Oman, UAE, Saudi Arabia are single payer systems, simple approval process, no need to refrigerate for 30 days which also lends itself well to Mexico, India, S Africa, Brazil. Mike wants the fastest path to approval, market access. We want partnership with upfront money now. The superior label would catalyze the recap, partnership, pipeline, payor coverage, adoption, No PA, No Step therapy.
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Post by lakers on Sept 26, 2017 18:00:58 GMT -5
1. Why India, S Africa? Possible partnership with Cipla?
Cipla Limited is an Indian multinational pharmaceutical and biotechnology company, headquartered in Mumbai, India. Cipla primarily develops medicines to treat cardiovascular disease, arthritis, diabetes, weight control and depression; other medical conditions.
Cipla Medpro, a 100% subsidiary of Cipla Limited, has a strong presence across therapies in the Republic of South Africa. Cipla also won government tenders in antiretrovirals (ARV), respiratory and newer areas such as mental health, cardiovascular and women’s health categories.
Cipla’s manufacturing facility at Durban provides a competitive edge and is the first Pharmaceutical Inspection Convention (PIC) compliant facility in the country. The brand inspires trust and has become a household name amongst consumers, pharmacies, prescribers and key opinion leaders.
Cipla has a clear commitment to provide access to Africa and other LDCs (Least Developed Countries). Cipla Quality Chemical Industries Limited ( CiplaQCIL ) is a state of the art manufacturing plant in Uganda that manufactures WHO prequalified anti-retrovirals antimalarials and antivirals for the treatment of hepatitis B. The plant is the largest in East Africa and supplies the Ugandan market and exports to East Africa, Cameroon and various markets in southern Africa. CiplaQCIL is currently expanding its portfolio to manufacture medicines for tropical diseases such as sleeping sickness, worm infestations and hepatitis C.
2. Partnership with Takeda in Japan?
3. Why UAE, Oman (new), Saudi Arabia (new)?
Gulf states with similar approval process. National Health Care.
4. Why Mexico?
No need for refrigeration for 30 days.
Pharmaceutical Import Regulation in Mexico. Issues / Trade barrier • Mexico imposes higher average tariff on finished products than on raw materials. – Inpharmaceuticals,althoughtheaveragetariffrateofthesemi‐processed products is a litter lower than that of the raw materials, the average tariff rate of the finished products is still much higher than that of the raw materials. • North American Free Trade Agreement (NFTA) agreement strengthened IP Rights and provide favorable environment for innovator companies. • NFTA eliminated import duty for US & Canada. – While US & Canada enjoy no import duty(Post NFTA), other country face average tariffs of 18%, providing both US & Canada with a competitive advantage over their overseas exporters. • In view of no generic drug registration fee in US which is the largest generic market globally; the registration fee for generic drugs in Mexico could be considered high.
Prospects in Mexican market • Under New regulation (Aug 2008) overseas Pharmaceutical producer no longer need to have local manufacturing facilities in order to operate in Mexico. Such requirement will be phased out over two years [COFERPRIS 2008] – Initially this requirement was introduced to promote investment in the country but have resulted in lack of competition and subsequently higher prices of medicine.
Important Points to Keep in Mind
The process for making a drug available in the public health system is as follows:
1. Secure regulatory approval from COFEPRIS
2. Petition for inclusion in the Health Systems Supply Catalogue
3. Once listed, the drug may be prescribed by any doctor within the public health system
In the case where a drug is not approved for general use, a demonstration of immediate need can be submitted to a Ministry of Health committee for special approval on a case-by-case basis.
Once drugs have been added to the Social Health Services Register, pricing is determined by institutional agreement between the manufacturers and payers. A drug’s value and price in the private system is determined by the market and in the public sector via public tender and subsequent negotiations (see compras consolidadas below). Though COFEPRIS sets the maximum price limits on drugs and procedures, the shelf price of a drug under this limit is ultimately left up to the manufacturer.
For delivery of medical services, including prescription drugs, those covered under the public health system are limited to attending (and receiving prescriptions from) federal- and state-run hospitals. Federal hospitals accept all forms of insurance, public and private, but private clinics only extend benefits, including medications, to those who have private insurance (or if that person can pay out-of-pocket).
Financial schemes and performance-based agreements have become commonplace in the Mexican pharmaceutical market:
1.Financial: Since 2013, “compras consolidadas” (consolidated purchases) have emerged as a key mechanism by which the government purchases medicines for publicly funded insurance schemes. In doing so, the government’s numerous entities and health insurance programs combine their negotiating power to obtain discounts and secure price/volume guarantees from manufacturers. In doing so, the government aims to achieve efficient, transparent and effective use of public resources.
2.Performance-based: Risk-sharing arrangements (RSAs) have also emerged as a key practice in Mexico. In these arrangements, authorities transfer some of the risks (both financial and in effectiveness) to manufacturers in exchange for government purchases of branded medicines.
In the private system, major retailers such as Wal-Mart (Walmex) and Fármacos Nacionales have traditionally held tremendous influence over the availability and pricing of medicines. However, this influence has been drawn into question due to the case of Casa Saba’s pharmacy, which prior to 2014 was the largest retail chain in Mexico. The pharmacy chain liquidated its assets and dismantled its Mexico operations at the same time that it owed $7 billion pesos to more than 500 pharmaceutical and device suppliers. This action resulted in millions in fines for the company’s previous owners, and a wake-up call for industry.
Overall, access into the Mexican healthcare market is largely dependent on demonstrated value. Private payers make decisions based on the value of a medication to patients’ health, and public health systems choose to include medication in their catalogue based on the value to the population.
5. Why China?
Most populous, AMPH has 1st right of refusal for partnership.
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Post by lakers on Sept 25, 2017 14:58:10 GMT -5
International expansion announcement is something we saw where we’re focused on.
Receptor Life Sciences, we’re looking to bring more clarity to that collaboration for our shareholders.
Going forward, we expect to be able to remove prior authorizations and continue to gain more coverage with additional plan. Our STAT trial, which is really looking at Afrezza plus Dexcom will be – we’ll get those results in late fall and they’ll be presented next year, and we’re on track for an IND filing for Treprostinil.
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Post by lakers on Sept 25, 2017 11:34:39 GMT -5
Targeted countries: Canada, Mexico, B, I, C (BRIC w/o R), Australia, Japan (new), Saudi Arabia (new), UAE, Oman (new), S Africa (new). That's > 50% of the World’s Population.
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Post by lakers on Sept 25, 2017 11:02:29 GMT -5
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